A Pilot Study of an Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure
研究概览
简要总结
Background:
- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also include other minimally invasive tumor treatments such as transarterial chemoembolization (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a cure. Researchers want to learn more about the effects of TACE on liver tumors and surrounding tissue. To do this, they will use a positive emission test (PET) and a radioactive tracer called [18F] FMISO.
Objectives:
- To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE.
Eligibility:
- People age 18 and older with liver cancer who have been approved to have TACE.
Design:
- Participants will meet with a study researcher to see if they can take part in the study.
- Participants will have TACE under a separate NCI protocol or at a hospital other than the NIH Clinical Center.
- Before and after TACE, participants will have a CT and MRI of the abdomen. For these scans, they will lie in a machine that takes pictures of their body. They will also have blood tests and a physical exam.
- The [18F] FMISO imaging study will be performed at NIH only.
- Participants will have an intravenous catheter placed in their arm (if they do not have one). The [18F] FMISO tracer will be injected.
- Participants will have PET-CT scans. Each scan will take about 30 minutes.
- Some participants will also have [18F] FMISO and PET-CT scans before TACE.
- As part of standard care for TACE, participants will have CT and MRI scans at regular intervals. This will evaluate tumor response.
详细描述
Background
- TACE is the standard therapy for inoperable primary liver cancers or tumor control prior to transplantation. The mechanisms for TACE s failure remains poorly understood.
- Although acute hypoxia and significant tumor necrosis occurs following TACE, the tumor adaptive response and localization for such have not been well characterized.
- Imaging tools using a hypoxia-specific tracer [(18)F] FMISO may help identify the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor progression.
- The primary hypothesis of this study states that tumor progression post-TACE arises from changes in tumor phenotype induced by treatment-related hypoxia superimposed on the dynamic process of underlying tumor hypoxia.
Objectives
-To determine the feasibility of hypoxic tumor identification despite relatively high liver background signal, and describe patterns of tumor hypoxia in the immediate post-TACE treatment period using PET imaging [(18)F] MISO uptake registered with cross-sectional imaging.
Eligibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
[18F] FMISO PET scan
Patients with primary hepatic malignancy who underwent [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure
干预措施: [18F] FMISO (Drug)
结局指标
主要结局
Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure
时间窗: up to 72 hours after injection of [18F] FMISO
A single dose of study imaging agent \[18F\] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.
次要结局
未报告次要终点